Tissue Repository: CTCL Collection Protocol

Description

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.

Conditions

Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis, Sézary Syndrome

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Study Overview

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Study Details

Study overview

This document is a protocol for a non-interventional human research study in which the investigator hopes to better understand the changes that take place in T cells in Cutaneous T-cell lymphoma (CTCL). The purpose of this study is to establish a protocol for the collection and storage of tissue samples from patients with CTCL for future research studies. Collection and storage of tissue samples from control patients will also be carried out.

A Tissue Repository for the Collection of Samples From Patients With Cutaneous T Cell Lymphoma and Healthy Volunteers

Tissue Repository: CTCL Collection Protocol

Condition
Lymphoma, T-Cell, Cutaneous
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients with CTCL or Lymphomatoid Papulosis (LYP): a clinical or histologic diagnosis of a) newly diagnosed, b) progressive, or c) relapsed CTCL or LYP who are initiating or changing therapy.
  • * Patients with Sézary Syndrome (SS) or stage IV B CTCL as defined by blood involvement on flow cytometry or morphology: (1) ≥1000/μL Sézary cells by morphology; (2) Cluster of differentiation 4 (CD4)/cluster of differentiation 8 (CD8) ratio ≥10; (3) CD4+cluster of differentiation 7 (CD7)- cells ≥40 percent; (4) or CD4+cluster of differentiation 26 (CD26)- cells ≥30 percent.
  • * Ability to understand and willing to sign a willing informed consent document.
  • * Age ≥ 18 years.
  • * Matched for sex, and age +/- 10 years.
  • * Ability to sign informed consent document.
  • * Patients with or without benign inflammatory skin conditions including, but not limited to, eczema, psoriasis, or dermatitis or Patients without skin conditions requiring treatment with systemic immunosuppressive, biologic, or chemotherapeutic agents.
  • * Patients with a history of previous lymphoma other than CTCL or SS or LYP.
  • * Medical illnesses with potential suppressive or activating impact on immune and bowel function as judged by the investigator.
  • * Current, viable pregnancy.
  • * Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.
  • * Previous history of CTCL, SS, LYP, or any lymphoma.
  • * Previous history of Human Immunodeficiency Virus (HIV) infection.
  • * Anemia with a documented hemoglobin laboratory value of \<7.5 g/dl within the past 6 months.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Columbia University,

Larisa J. Geskin, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2025-01